ZELTIQ CoolSculpting System, Руководство пользователя

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System Overview ZELTIQ Clinical Studies
User Manual 11
In this study, 60 subjects were enrolled at three clinical sites. Sixty initial treatments were performed with the
prototype CoolMini vacuum applicator; 59 subjects were re-treated at the 6-week follow-up visit. Treatments
were performed at -10°C for 60 minutes. Follow-up data is available through 12 weeks post-treatment. Subject
safety was assessed throughout the study.
The primary safety endpoint was the measurement of all device- or procedure-related adverse events. All
adverse events reported during and after the treatment were included in the safety analysis. The primary
safety endpoint was met. No device- or procedure-related serious adverse events (SAE) and no unanticipated
adverse device effects (UADE) occurred during the study. Four device- or procedure-related adverse events
were reported and have resolved. Clinical safety assessment showed anticipated side-effects, all of which
resolved over the course of the study. The safety data recorded during this study supports the safety of the
treatment parameters and device investigated.
The primary efficacy endpoint was correct identification of pre-treatment vs. 12-week post-final treatment
images by 3 blinded independent reviewers. The overall correct identification rate by the 3 reviewers was 91%
for the per-protocol population (n=58), which met the pre-established 80% criterion for success. The primary
efficacy endpoint was met.
Reduction in subcutaneous fat layer thickness as measured by ultrasound at 12-weeks post-final treatment was
a secondary efficacy endpoint for this study. Analysis of the per-protocol data (57 subjects) showed a
statistically significant (p<0.0001) reduction of 0.20 cm. Therefore, the secondary efficacy endpoint for
reduction of fat layer thickness was met.
The secondary efficacy endpoint for subject satisfaction was assessed by a questionnaire administered at 12
weeks post-final treatment. Overall, 83.3% of subjects enrolled in the study indicated they were satisfied with
the treatment and 80% reported that they would recommend the treatment to a friend.
These clinical findings demonstrate that use of the CoolSculpting System can safely and effectively affect the
appearance of visible fat bulges in the submental area with treatment at -10°C for 60 minutes.
Summary of Upper Arm Study
ZELTIQ conducted a clinical investigation to evaluate the safety and efficacy of cryolipolysis for non-invasive
reduction of upper-arm fat.
In this study, 30 subjects were enrolled at two clinical sites. Sixty initial treatments were performed with a
prototype of the CoolAdvantage applicator (CoolFit with aluminum Insert). Each subject was treated once on
each upper arm, at -11°C for 35 minutes. Follow-up data is available through 12 weeks post-treatment. Subject
safety was assessed throughout the study.
The primary safety endpoint was the incidence of unanticipated adverse device effects. Clinical safety
assessment showed anticipated side-effects. There were 4 patients with prolonged numbness lasting greater
than 12 weeks. No unanticipated adverse device effects, or serious device- or procedure-related adverse
effects occurred. All device- and/or procedure-related adverse events resolved spontaneously. The primary
safety endpoint was met.
The primary efficacy endpoint involved independent panel review of pre- and 12-week post-treatment
photographs of the treatment area for discernible fat layer reduction. The per protocol population consisted of
all the treated subjects followed for 12 weeks with weight change of no more than 5% of total body weight at
the time the 12 week images were taken. For the per protocol population, the correct baseline photograph
identification rate by the independent panel reviewers was 85.2% [72.9%, 93.4%].
Further evidence of treatment efficacy is found in the data from ultrasound measurements of fat reduction at
the treated areas, with significant reduction in the fat layer (0.32 cm) from baseline to 12 weeks post-
treatment.
The secondary efficacy endpoint for subject satisfaction was assessed by an IRB-approved questionnaire
administered at 12 weeks post-treatment. 72.41% of the subjects found the procedure to be comfortable to
very comfortable, and 63.3% of the subjects reported that they would recommend the procedure to a friend.